Primary trabeculectomy for advanced glaucoma: pragmatic multicentre randomised controlled trial (TAGS)

Area of Science:

• Ophthalmology
• Clinical Trials
• Glaucoma Research

Background:

• Advanced open-angle glaucoma requires effective treatment to preserve vision and quality of life.
• Comparing surgical intervention (trabeculectomy) with medical management is crucial for treatment guidelines.

Purpose of the Study:

• To compare the clinical effectiveness, safety, and quality of life outcomes of primary trabeculectomy versus primary medical treatment in patients with newly diagnosed advanced open-angle glaucoma.

Main Methods:

• A pragmatic, multicentre, randomised controlled trial involving 453 adults across 27 UK secondary care departments.
• Participants were randomised to either mitomycin C augmented trabeculectomy (n=227) or escalating medical management (n=226).
• Outcomes included vision-specific quality of life (VFQ-25) at 24 months, intraocular pressure, visual field, visual acuity, and safety.

Main Results:

• At 24 months, no significant difference in vision-specific quality of life was observed between the trabeculectomy and medical arms (mean VFQ-25 scores 85.4 vs 84.5, P=0.38).
• Trabeculectomy resulted in significantly lower intraocular pressure (12.4 mm Hg) compared to medical management (15.1 mm Hg) (P<0.001).
• Adverse event rates were similar between groups (39% vs 44%, P=0.37), with rare serious side effects.

Conclusions:

• Primary trabeculectomy offers comparable quality of life and safety outcomes to primary medical treatment for advanced glaucoma.
• Trabeculectomy demonstrates superior efficacy in reducing intraocular pressure compared to medical management.
• These findings support trabeculectomy as a viable primary treatment option for selected patients with advanced glaucoma.